A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection in Patients With Multiple Myeloma

Official Title ICMJE

A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma

Brief Summary

This study is planned to monitor safety and assess bioequivalence of Doxorubicin Hydrochloride Liposome injection- Test and Reference, administered as 2 mg/ml injection (30 mg/m2 dose) in patients with Multiple myeloma. Patients will receive Test and Reference drug with an interval of 21 days between the doses. In this study, blood samples will be collected during and after the infusion.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

24

Completion Date

April 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Availability for the entire study period and willingness to adhere to protocol requirements.

Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome

18 years of age or older

No evidence of underlying disease (except multiple myeloma)

Informed consent form given in written form according

Female patients of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies,diaphragm, intrauterine device (IUD), or abstinence postmenopausal for at least 1 year surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

History or presence of significant:

Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride